FDA.reportPublic FDA data

MARK3

Primary DI
D7961318LA1
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
1318LA
Catalog number
1318LA
Device description
Premium Bibs Lavender 3Ply 13" x 18" 500/bx. - MARK3®*
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7961318LA1PrimaryHIBCC0
D7961318LA0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Saliva absorbentA non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
845-267-2600info@cargus.com

Regulatory Flags#

DUNS number
096191093
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
D7969003MARK390032025-03-06
D7969001MARK390012025-02-28
00850014374532MARK3855-016XC855-016XC2024-07-24
00850014374549MARK3848-018XC848-018XC2024-07-24
00850014374556MARK3652S-018XC652S-018XC2024-07-24
00850014374563MARK3655S-018XC655S-018XC2024-07-24
00850014374570MARK3855-018C855-018C2024-07-24
00850014374587MARK3652S-017XC652S-017XC2024-07-24
D79616501MARK3165016502024-07-22
D79616521MARK3165216522024-07-22
D79616541MARK3165416542024-07-22
D79614260MARK3142614262023-11-15
D7961426X0MARK31426X1426X2023-11-15
D79614300MARK3143014302023-11-15
D79614320MARK3143214322023-11-15
D79614330MARK3143314332023-11-15
D79619112MARK3191119112023-11-09
D79619122MARK3191219122023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126508201Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKHR2026-03-12
00840456201442JMUJMU DENTAL, INCKHR2025-12-11
00840456201459JMUJMU DENTAL, INCKHR2025-12-11
00840456201466JMUJMU DENTAL, INCKHR2025-12-11
00840456201473JMUJMU DENTAL, INCKHR2025-12-11
00840456201480JMUJMU DENTAL, INCKHR2025-12-11
00840456201497JMUJMU DENTAL, INCKHR2025-12-11
00840456201503JMUJMU DENTAL, INCKHR2025-12-11
00840456201510JMUJMU DENTAL, INCKHR2025-12-11
00840456202753JMUJMU DENTAL, INCKHR2025-12-11
00840456202760JMUJMU DENTAL, INCKHR2025-12-11
00840456202777JMUJMU DENTAL, INCKHR2025-12-11
00840456202784JMUJMU DENTAL, INCKHR2025-12-11
00840456215142JMUJMU DENTAL, INCKHR2025-12-11
00840456215159JMUJMU DENTAL, INCKHR2025-12-11
00840456215609JMUJMU DENTAL, INCKHR2025-12-11
00840456215616JMUJMU DENTAL, INCKHR2025-12-11
00840456217191JMUJMU DENTAL, INCKHR2025-12-11
00840456217207JMUJMU DENTAL, INCKHR2025-12-11
00840456217214JMUJMU DENTAL, INCKHR2025-12-11
00840456217221JMUJMU DENTAL, INCKHR2025-12-11
00840456217238JMUJMU DENTAL, INCKHR2025-12-11
00840456217245JMUJMU DENTAL, INCKHR2025-12-11
00840456217252JMUJMU DENTAL, INCKHR2025-12-11
00840456217269JMUJMU DENTAL, INCKHR2025-12-11
00840456217276JMUJMU DENTAL, INCKHR2025-12-11
00840456217283JMUJMU DENTAL, INCKHR2025-12-11
00840456217290JMUJMU DENTAL, INCKHR2025-12-11
00840456217306JMUJMU DENTAL, INCKHR2025-12-11
00840456217313JMUJMU DENTAL, INCKHR2025-12-11